[Federal Register Volume 68, Number 231 (Tuesday, December 2, 2003)]
[Rules and Regulations]
[Pages 67365-67367]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-29863]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 872

[Docket No. 2002N-0305]


Medical Devices: Classification of the Dental Sonography Device 
and Jaw Tracking Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is classifying the 
dental sonography device into class I, when it is used to monitor 
temporomandibular joint sounds, and into class II, when it is used to 
interpret temporomandibular joint sounds for the diagnosis of 
temporomandibular joint disorders and associated orofacial pain. FDA is 
classifying the jaw tracking device into class I, when it is used to 
monitor mandibular jaw positions relative to the maxilla, and into 
class II, when it is used to interpret mandibular jaw positions 
relative to the maxilla, for the diagnosis of temporomandibular joint 
disorders and associated orofacial pain. Elsewhere in this issue of the 
Federal Register, FDA is announcing the availability of a guidance 
document that will serve as the special control for this device. FDA is 
taking this action under the Federal Food, Drug, and Cosmetic Act (the 
act) as amended by the Medical Device Amendments of 1976 (the 1976 
amendments), the Safe Medical Devices Act of 1990 (the SMDA), the Food 
and Drug Administration Modernization Act of 1997 (FDAMA) and the 
Medical Device User Fee and Modernization Act of 2002 (MDUFMA).

DATES: This rule is effective January 2, 2004.

FOR FURTHER INFORMATION CONTACT: Mary S. Runner, Center for Devices and 
Radiological Health (HFZ-480), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-827-5283.

SUPPLEMENTARY INFORMATION:

I. Background

    The act (21 U.S.C. 301 et seq.), as amended by the 1976 amendments 
(Public Law 94-295), the SMDA (Public Law 101-629), and FDAMA (Public 
Law 105-115), established a comprehensive system for the regulation of 
medical devices intended for human use. Section 513 of the act (21 
U.S.C. 360c) established three categories (classes) of devices as a 
function of the regulatory controls needed to provide reasonable 
assurance of their safety and effectiveness. The three categories of 
devices are class I (general controls), class II (special controls), 
and class III (premarket approval).
    Under section 513 of the act, FDA refers to devices that were in 
commercial distribution before May 28, 1976 (the date of enactment of 
the 1976 amendments), generally referred to as preamendments devices, 
are classified after FDA has: (1) Received a recommendation from a 
device classification panel (an FDA advisory committee); (2) published 
the panel's recommendation for comment, along with a proposed 
regulation classifying the device; and (3) published a final regulation 
classifying the device. FDA has classified most preamendments devices 
under these procedures.
    Devices that were not in commercial distribution before May 28, 
1976, generally referred to as postamendments devices, are classified 
automatically by statute (section 513(f) of the act) into class III 
without any FDA rulemaking process. Those devices remain in class III 
and require premarket approval, unless and until FDA does the 
following: (1) Reclassifies the device into class I or II; (2) issues 
an order classifying the device into class I or II in accordance with 
new section 513(f)(2) of the act, as amended by FDAMA; or (3) issues, 
under section 513(i) of the act, an order finding the device as 
substantially equivalent to a predicate device that does not require 
premarket approval. FDA determines whether new devices are 
substantially equivalent to preamendments devices by means of premarket 
notification procedures as delineated in section 510(k) of the act (21 
U.S.C. 360(k)) and part 807 of the regulations (21 CFR part 807).
    Through premarket notification procedures, a person may, without 
submission of a premarket approval application (PMA), market a 
preamendments type device that has been classified into class III until 
FDA issues a final regulation under section 515(b) of the act (21 
U.S.C. 360e(b)) requiring premarket approval. Consistent with the act 
and the regulations, FDA consulted with the Dental Products Advisory 
Panel (the Panel), an FDA advisory committee, regarding the 
classification of the dental sonography device and the jaw tracking 
device.

II. Regulatory History of the Device

    In the Federal Register of August 14, 2002 (67 FR 52901), FDA 
proposed to classify the dental sonography device into class I when it 
is used to monitor temporomandibular joint sounds, and into class II, 
when it is used to interpret temporomandibular joint sounds for the 
diagnosis of temporomandibular joint disorders and associated orofacial 
pain. FDA also proposed to classify the jaw tracking device into class 
I, when it is used to monitor mandibular jaw positions relative to the 
maxilla, and into class II, when it is used to interpret mandibular jaw 
positions relative to the maxilla, for the diagnosis of 
temporomandibular joint disorders and associated orofacial pain.
    FDA provided an opportunity for interested persons to comment on 
the proposed regulation and guidance document until November 12, 2002. 
FDA received one comment from a consumer, however, the comment was 
irrelevant to the proposed rule because it was referring to a different 
device. A manufacturer commented that the identification of the class 
II sonography could be read to place a device in class II even if it 
does not interpret sounds. The comment said that a device is 
appropriately in class II if it interprets sounds. The comment further 
suggested that FDA should define ``interpret'' to mean that the device 
provides a specific diagnosis and not just meaningful output.
    FDA agrees that the identification may not have been clear and has 
revised Sec.  872.2050(b) by combining the last two sentences to 
clarify that interpretation is a necessary part of the identification. 
FDA disagrees that ``interpret'' should mean that a device provides a 
specific diagnosis. FDA believes that it is necessary that the 
manufacturer of a class II dental sonography device that

[[Page 67366]]

goes beyond a simple display of raw data should provide clinical 
information and verification that the information provided by these 
devices has clinical and diagnostic validity, sensitivity, and 
specificity and, therefore, the special control, in addition to the 
general controls, is necessary to provide reasonable assurance of 
safety and effectiveness.

III. Summary of Final Rule

    FDA concurs that the dental sonography device and the jaw tracking 
device, used to monitor temporomandibular joint sounds and mandibular 
jaw positions relative to the maxilla, respectively, should be 
classified into class I (general controls). General controls would 
provide reasonable assurance of safety and effectiveness for these 
devices for these intended uses. FDA, however, believes that the dental 
sonography device and the jaw tracking device used to interpret 
temporomandibular joint sounds and mandibular jaw positions relative to 
the maxilla, respectively, for the diagnosis of temporomandibular joint 
disorders and associated orofacial pain should be classified into class 
II (special controls). Premarket notification for dental sonography and 
jaw tracking devices with these intended uses should include clinical 
information to demonstrate performance, as well as labeling instructing 
the user on proper technique, interpretation of the device outputs, and 
appropriate warnings and precautions. FDA concurs with the Panel's 
recommendation that these devices should be subject to sale by or on 
the order of a licensed practitioner.
    FDA disagrees with the Panel that the class I devices should 
require premarket notification because they meet the reserved criteria 
of section 510(l) of the act. FDA believes that the intended uses of 
monitoring sounds emanated from the temporomandibular joint or 
monitoring mandibular jaw positions relative to the maxilla should be 
exempt from premarket notification. FDA believes these devices for 
these intended uses are not of substantial importance in preventing 
impairment of human health, nor do they present an unreasonable risk of 
illness or injury.
    FDA, however, is classifying into class II, the dental sonography 
device and the jaw tracking device used to interpret temporomandibular 
joint sounds and mandibular jaw positions relative to the maxilla, 
respectively, for the diagnosis of temporomandibular joint disorders 
and associated orofacial pain. Section 510(m) of the act provides that 
a class II device may be exempted from the premarket notification 
requirements, if FDA determines that premarket notification is not 
necessary to provide reasonable assurance of safety and effectiveness. 
FDA concludes that premarket notification is necessary.
    FDA has identified the following risks to health associated with 
the class II devices as follows: (1) Electrical interference. 
Electrical interference generated by these devices may affect 
diagnostic and therapeutic medical devices, such as certain types of 
cardiac pacemakers; (2) Improper treatment. There is no general 
consensus or established standard of care regarding the interpretation 
of the output of these devices. Therefore, a misdiagnosis of 
temporomandibular joint disorders and associated orofacial pain may 
lead to improper treatment.

IV. Special Controls Guidance Document

    Elsewhere in this issue of the Federal Register, FDA is announcing 
the availability of the guidance document entitled ``Class II Special 
Controls Guidance Document: Dental Sonography and Jaw Tracking 
Devices.'' This guidance document will serve as the special control for 
the class II dental sonography and jaw tracking devices.
    FDA believes that review of performance characteristics described 
in the special controls guidance and appropriate labeling can ensure 
that acceptable levels of performance for both safety and effectiveness 
are addressed before marketing clearance. Thus, persons who intend to 
market this device must submit to FDA a premarket notification 
submission before marketing the device. Following the effective date of 
the final classification rule, any firm submitting a 510(k) premarket 
notification for these class II devices will need to address the issues 
covered in the special control guidance. However, the firm need only 
show that its device meets the recommendations of the guidance or in 
some other way provides equivalent assurances of safety and 
effectiveness.

V. Environmental Impact

    The agency has determined under 21 CFR 25.34(b) that this 
classification action is of a type that does not individually or 
cumulatively have a significant effect on the human environment. 
Therefore, neither an environmental assessment nor an environmental 
impact statement is required.

VI. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the 
Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1501 et seq.). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives. If regulation is necessary, a 
regulatory agency must plot a course that maximizes net benefits 
(including potential economic, environmental, public health and safety, 
and other advantages; distributive impacts; and equity). The agency 
believes this final rule is consistent with the regulatory philosophy 
and principles identified in the Executive order. Additionally, as 
defined by the Executive order the final rule does not constitute a 
significant regulatory action. As a result, the final rule is not 
subject to review under the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. The class I devices are already subject to the 
general controls provisions of the act. The special controls guidance 
does not impose any new requirements on manufacturers of class I 
devices. Manufacturers of the class II dental sonography and jaw 
tracking devices currently are required to submit premarket 
notifications. The guidance document reflects existing FDA practice in 
the review of these premarket notifications. FDA expects that 
manufacturers of cleared dental sonography and jaw tracking devices 
will not have to take any additional action in response to this rule. 
This rule will help expedite the review process for any new 
manufacturers of these devices. The agency therefore certifies that the 
final rule will not have a significant economic impact on a substantial 
number of small entities. In addition, this final rule will not impose 
costs of $100 million or more on either the private sector or State, 
local, and tribal governments in the aggregate, and therefore a summary 
statement of analysis under section 202(a) of the Unfunded Mandates 
Reform Act of 1995 is not required.

VII. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have

[[Page 67367]]

federalism implications as defined in the Executive order and, 
consequently, a federalism summary impact statement is not required.

VIII. Paperwork Reduction Act of 1995

    FDA concludes that the final rule contains no collections of 
information. Therefore, clearance by the Office of Management and 
Budget, according to the Paperwork Reduction Act of 1995 (44 U.S.C. 
3501-3520) is not required.

List of Subjects in 21 CFR Part 872

    Medical devices.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
872 is amended as follows:

PART 872--DENTAL DEVICES

0
1. The authority citation for 21 CFR part 872 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Section 872.2050 is added to subpart B to read as follows:


Sec.  872.2050  Dental sonography device.

    (a) Dental sonography device for monitoring--(1) Identification. A 
dental sonography device for monitoring is an electrically powered 
device, intended to be used to monitor temporomandibular joint sounds. 
The device detects and records sounds made by the temporomandibular 
joint.
    (2) Classification. Class I. The device is exempt from the 
premarket notification provisions of subpart E of part 807 of this 
chapter subject to Sec.  872.9.
    (b) Dental sonography device for interpretation and diagnosis--(1) 
Identification. A dental sonography device for interpretation and 
diagnosis is an electrically powered device, intended to interpret 
temporomandibular joint sounds for the diagnosis of temporomandibular 
joint disorders and associated orofacial pain. The device detects, 
records, displays, and stores sounds made by the temporomandibular 
joint during jaw movement. The device interprets these sounds to 
generate meaningful output, either directly or by connection to a 
personal computer. The device may be part of a system of devices, 
contributing joint sound information to be considered with data from 
other diagnostic components.
    (2) Classification. Class II (special controls). The special 
control for this device is FDA's guidance document entitled ``Class II 
Special Controls Guidance Document: Dental Sonography and Jaw Tracking 
Devices.''
0
3. Section 872.2060 is added to subpart B to read as follows:


Sec.  872.2060  Jaw tracking device.

    (a) Jaw tracking device for monitoring mandibular jaw positions 
relative to the maxilla--(1) Identification. A jaw tracking device for 
monitoring mandibular jaw positions relative to the maxilla is a 
nonpowered or electrically powered device that measures and records 
anatomical distances and angles in three dimensional space, to 
determine the relative position of the mandible with respect to the 
location and position of the maxilla, while at rest and during jaw 
movement.
    (2) Classification. Class I (general controls). The device is 
exempt from the premarket notification provisions of subpart E of part 
807 of this chapter subject to Sec.  872.9.
    (b) Jaw tracking device for interpretation of mandibular jaw 
positions for the diagnosis--(1) Identification. A jaw tracking device 
for interpretation of mandibular jaw positions relative to the maxilla 
for the diagnosis of temporomandibular joint disorders and associated 
orofacial pain is a nonpowered or electrically powered device that 
measures and records anatomical distances and angles to determine the 
relative position of the mandible in three dimensional space, with 
respect to the location and position of the maxilla, while at rest and 
during jaw movement. The device records, displays, and stores 
information about jaw position. The device interprets jaw position to 
generate meaningful output, either directly or by connection to a 
personal computer. The device may be a part of a system of devices, 
contributing jaw position information to be considered with data from 
other diagnostic components.
    (2) Classification. Class II (special controls). The special 
control for this device is FDA's guidance document entitled ``Class II 
Special Controls Guidance Document: Dental Sonography and Jaw Tracking 
Devices.''

    Dated: October 23, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-29863 Filed 12-1-03; 8:45 am]
BILLING CODE 4160-01-S